http://informahealthcare.com/dre ISSN 0963-8288 print/ISSN 1464-5165 online Disabil Rehabil, 2015; 37(4): 311–318 ! 2015 Informa UK Ltd. DOI: 10.3109/09638288.2014.918191
RESEARCH PAPER
The optimal frequency of aquatic physiotherapy for individuals with chronic musculoskeletal pain: a randomised controlled trial Antonio I. Cuesta-Vargas1,2, Melanie White3, Manuel Gonza´lez-Sa´nchez1, and Raija Kuisma3
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1
Departamento de Psiquiatrı´a y Fisioterapia, Instituto de Biomedicina de Ma´laga (IBIMA), Grupo de Clinimetria (AE-14), Universidad de Malaga, Andalucia Tech, Malaga, Spain, 2School of Clinical Sciences, Queensland University of Technology, Brisbane, Australia, and 3School of Health Professions, University of Brigthon, Brigthon, UK Abstract
Keywords
Purpose: To establish whether there was a difference in health-related quality of life (HRQoL) in people with chronic musculoskeletal disorders (PwCMSKD) after participating in a multimodal physiotherapy program (MPP) either two or three sessions a week. Methods: Total of 114 PwCMSKD participated in this prospective randomised controlled trial. An individualised MPP, consisting of exercises for mobility, motor-control, muscle strengthening, cardiovascular training, and health education, was implemented either twice a week (G2: n ¼ 58) or three times a week) (G3: n ¼ 56) for 1 year. Outcomes: HRQoL physical and mental health state (PHS/MHS), Roland Morris disability Questionnaire (RMQ), Neck-Disability-Index (NDI) and Western Ontario and McMaster Universities’ Arthritis Index (WOMAC) were used to measure outcomes of MPP for people with chronic low back pain, chronic neck pain and osteoarthritis, respectively. Measures were taken at baseline, 8 weeks (8 w), 6 months (6 m), and 1 year (1 y) after starting the programme. Results: No statistically significant differences were found between the two groups (G2 and G3), except in NDI at 8 w (3.34, (CI 95%: 6.94/0.84, p ¼ 0.025 (scale 0–50)). All variables showed improvement reaching the following values (from baseline to 1 y) G2: PHS: 57.72 (baseline: 41.17; (improvement: 16.55%), MHS: 74.51 (baseline: 47.46, 27.05%), HRQoL 0.90 (baseline: 0.72, 18%)), HRQoL-VAS 84.29 (baseline: 58.04, 26.25%), RMQ 4.15 (baseline: 7.85, 15.42%), NDI 3.96 (baseline: 21.87, 35.82%), WOMAC 7.17 (baseline: 25.51, 19.10%). G3: PHS: 58.64 (baseline: 39.75, 18.89%), MHS: 75.50 (baseline: 45.45, (30.05%), HRQoL 0.67 (baseline: 0.88, 21%), HRQoL-VAS 86.91 (baseline: 52.64, 34.27%), RMQ 4.83 (baseline: 8.93, 17.08%), NDI 4.91 (baseline: 23.82, 37.82%), WOMAC 6.35 (baseline: 15.30, 9.32%). Conclusions: No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at 8 weeks, but both groups improved in all variables during the course of 1 year under study.
Chronic musculoskeletal disorders, exercise dose, frequency, health-related quality of life, physiotherapy History Received 2 August 2013 Revised 23 February 2014 Accepted 22 April 2014 Published online 12 May 2014
ä Implications for Rehabilitation
A multimodal physiotherapy program (MPP) improves quality of life, overall health, and function in people with chronic musculoskeletal disease after an intervention of short, medium and long term. This implies that twice a week MPP for people with chronic musculoskeletal pain has comparable results to three times a week provision and therefore may have implications in saving resources and cost for patients and service providers without compromising the outcomes of treatment. These results can be considered not only for therapists, but also for managers who offer the services to optimise the balance cost-effectiveness of the proposed interventions.
Background There is contrasting evidence to suggest that chronic pain has a negative impact on physical and psychological health and wellbeing as well as a detrimental impact on activities of daily living,
Address for correspondence: Antonio I. Cuesta-Vargas, PhD, Facultad de Ciencias de la Salud, Universidad de Malaga, Andalucia Tech, Av/ Arquitecto Pen˜alosa s/n (Teatinos Campus Expansion), 29009 Malaga, Spain. Tel: 0034951 952 852. E-mail: [email protected]
employment and economics [1–3]. Chronic pain is a primary symptom of many musculoskeletal disorders, and can be exacerbated or eased by the management of these disorders [2]. Many people with chronic musculoskeletal disorders (CMSKD) have reported being unable to independently care for themselves due to their chronic pain, which impacts heavily on health-related quality of life (HRQoL) [3,4] and on their employment [5]. It is essential that the most effective methods in reducing pain in debilitating chronic diseases are used in their medical and physiotherapy management [6]. There are a multitude of
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guidelines on how to best manage chronic musculoskeletal conditions [7–10], all stating exercise as a common treatment modality. Exercise is considered as part of effective physiotherapy when it reaches a number of criteria, e.g. efficacy, effectiveness, appropriate dose, mechanisms of action and avoidance of potential adverse effects [11]. Recently ACSM guidelines have become more pertinent to populations with chronic diseases and disabilities where exercise is considered to be more relevant to quality of life as opposed to the extension of life [12]. These guidelines could be incorporated in a multimodal exercise programmes with psychological, educational and social aspects. There is strong evidence to support the implementation of these programmes for persons with chronic musculoskeletal diseases [13]. Aquatic exercise has been found to be beneficial for these populations [14–16]. For the CMSKD relevant to this study; chronic low back pain (CLBP), chronic neck pain (CNP) and osteo-arthritis (OA), the ACSM guidelines recommend two to three treatment sessions per week, stating however that ‘‘Many diseases and disabilities have yet to be sufficiently studied to yield exact dose-response information’’ [17]. Additionally, the National Institute for Health and Clinical Excellence (NICE) [8,18] provides incomplete guidelines for exercise dose and prescription and therefore warrant further research into this area. Furthermore, different systematic reviews and clinical practice guidelines have recommended the use of health education as part of physiotherapy programmes for CMSKD [7,8,10,13,14,18]. Some studies have looked into the frequency of exercise sessions comparing one and two sessions a week of aquatic physiotherapy [19], and two and three sessions a week [20] of land-based exercise. However, there is no specific research studies identified to date which investigates dose and frequency for up to three sessions a week of aquatic physiotherapy. In view of the limited evidence of the impact of frequency of exercise therapy on an individual’s quality of life, the aim of the current study was to establish whether there was a difference in HRQoL in people with CMSKD (PwCMSKD) when participating in a multimodal physiotherapy program (MPP) either two or three sessions a week, and whether any differences found between these groups are significant enough to recommend session frequency to be two or three times a week. The results of this study may have implications to the provision of the Aquatic therapy, the cost for the patients and providers and also compliance with the prescribed aquatic therapy programmes. Hypothesis0: there will be no significant differences in HRQoL and disability in PwCMSKD when attending 2 or 3 sessions of MPP.
Methods Study design The study design was experimental prospective study with pre-post intervention evaluation of the outcomes of a MPP, comparing two groups; G2 (2 times a week therapy) and G3 (3 times a week therapy). Data were collected between January 2010 and May 2012 in a community health centre in Torremolinos Spain. The patients were randomly assigned (using sealed envelopes) into one of the two groups either completing two sessions of MPP per week (G2) or three sessions of MPP per week (G3). Participants Inclusion criteria: CMSKD included in this study: chronic non-specific low back pain (CNLBP), chronic neck pain (CNP) or osteoarthritis (OA)) diagnosed by a general practitioner
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at least 12 weeks prior to commencement of the aquatic therapy or persistence pain over 12 weeks. The exclusion criteria were: contraindications to aquatic therapy therefore excluded from the MPP in water, osteoporosis, irregular attendance, infectious process, cognitive impairment of any aetiology, fractures, changes in pharmacological treatment during the intervention time, cancer with or without metastases. Specifically for the CLBP and CNP, patients were excluded if they suffered pain in the spine as a result of specific spinal pathology, nerve root pain/radiculopathy or had a current exacerbation of pain and spinal surgery within 6 months prior to recruitment. In addition, patients with OA were excluded if physical findings indicated the presence of inflammatory arthritis, infections or another autoimmune disease, surgery or trauma on knees and/or hips, within 6 months prior to recruitment. All participants were provided with information of the procedures of the study and they had to sign a written, informed consent before start of the study. Ethics approval from the Consejerı´a de Salud (Distrito Sanitario Costa Del Sol, Servicio Andaluz de Salud) (Spain) and The School of Health Professions Ethical Committee, University of Brighton (England) was obtained before the commencement of the study. The group assignment was randomised. Sealed envelopes were used to allocate each participant either to G2 or G3. The allocator was blinded and he did not know which number corresponded to each intervention group. Total of 131 volunteers were recruited, 17 of them were excluded for failing to meet the criteria for the study. The eligible 114 participants (36 CLBP – 38 CNP – 38 OA) began the MPP, 58 in G2 and 56 in G3. Of these, nine participants did not complete the 1 year long intervention, five in Gr2 and 2 in G3 due to attendance being less than 85% of the sessions in G3, one because moving to another city and another for personal reasons. The analysis of the results includes the data of the 114 participants who began the study. Figure 1 shows a complete flow chart of the participants. Intervention An individualised MPP intervention was implemented and each participant was interviewed and assessed individually by a physiotherapist at the start of their programme using the ASETER 2.0 [21] computer program, which includes a number of relevant lifestyle questions, including smoking, alcohol consumption, activity levels and lifestyle questions. In addition, a physical examination was undertaken to determine the level of functional ability including range of motion, quality of movements and motor control, muscular endurance and strength, and cardiovascular capacity. These however are not reported in this current paper. The therapist who performed the assessments was not involved in interventions with patients. Subsequently an individualised programme was designed involving 10 min of mobility exercise, 10 min training of motor control, 20 min resistance and muscle strengthening exercises and 20 min aerobic exercise in the form of deep water running (DWR) at 55–85% age-predicted maximal heart-rate (Figure 2). During the study the physiotherapist who led the sessions emphasised the importance of regular attendance and adherence to the MPP and also explained the purpose of the exercises and monitored their correct performance. Each session lasted for an hour and the programmes continued for a year, two or three sessions a week depending on which group the participants belonged to. The exercises were instructed and supervised by a physiotherapist and took place in groups in 29–30 C degrees water in a 180–200 cm deep therapy pool.
Optimal physiotherapy frequency for PwCMSKD
DOI: 10.3109/09638288.2014.918191
PRIMARY HEALTH CARE
SELF - DERIVED
SECONDARY HEALTH CARE
HEALTH SECTION (PMDT) PHYSIOTHERAPY SERVICE
VOLUNTARY (N=131) Randomization
GROUP 2 (N=58)
Losses n=5
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5 no adherence
EXCLUDED (n=17) Osteoporosis:n=4 Exercise Intolerance: n=3 Cognitive Impairment: n=1 Non Chronic MSKD=9
313
No Voluntary n=7
GROUP 3 (N=56)
Losses n=4 2 no adherence 1 personal reasons 1 change of city
HEALTH SECTION (PMDT) PHYSIOTHERAPY SERVICE FINAL TREATMENT (12 MOTHS) (N=105) PATIENTS ANALIZED (N=114) Figure 1. Description patient diagram.
Table 1. Table to show outcome measures used for each pathology. Musculoskeletal disorder CLBP
OA
CNP
Figure 2. Participant during deep water running execution.
Outcome measure used 1. Roland Morris Questionnaire (RMQ) 2. SF12: physical state of quality of life related-health (PHS) SF12: Mental state of quality of life related-health (MHS) 3. EuroQol score and VAS 1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) 2. SF12: PHS SF12: MHS 3. EuroQol score and VAS. 1. Neck-Disability-Index (NDI) 2. SF12:PHS SF12: MHS 3. EuroQol score and VAS
HRQoL was assessed by a group of qualified, experienced physiotherapists at the start of the programme (0 weeks), and then 8 weeks, 6 months and 1 year during the programme to determine whether short-term benefits as well as long-term benefits were gained as assessed with fore-mentioned outcome measures (Table 1). The therapists who conducted the assessment and MPP interventions use the outcome measures in their daily practice. They were unaware of which patients were part of this randomised controlled trial. The outcome measures used are deemed to be effective in measuring various aspects of HRQoL for this patient population, as well as being tested for validity and reliability [11,22–26]. The general health-related outcome measures used for all participants as well as specific measures for specific chronic disorders are outlined in Table 1.
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Outcome measures Each patient filled out three self-administered questionnaires, to measure the overall health and quality of life and one to measure disability caused by the specific musculoskeletal disorder. The outcome measures were general health state (physical and mental component), evaluated with the Short Form-12 Health Survey (SF-12) [22]; HRQoL, with the Spanish version of EuroQoL-5D (EuroQoL-5D and EuroQol-VAS [23] and specific disability indices for each musculoskeletal disorder: Roland Morris Questionnaire (RMQ) [24], for CLBP, Neck-DisabilityIndex (NDI) [25], for CNP, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) [26] for OA. The reliability of SF-12 has been shown to be 0.86–0.89 [22], EuroQoL between 0.86 and 0.90 [23], the RMQ Spanish version 0.87 [24], the NDI Spanish version 0.978 [25] and the WOMAC Spanish version between 0.81 and 0.93 [26].
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Data analysis and statistics Kolmogorov–Smirnov test was used to analyse the distribution of the data. To establish whether there were any significant differences between the baseline data for G2 and G3, an independent samples t-test was performed (Table 2). A repeated measures analysis of variance was used to examine statistically significant differences in each group at baseline (0 weeks), 8 weeks, 6 months and 1 year. Within this, sphericity and F values were found to establish the overall significance, as well as pair-wise comparisons to show where any significant values were within the data set. Non-parametric Mann–Whitney U test was employed to find any statistically significant differences between the groups on data that did not fulfil the criteria for parametric testing. Data analysis was performed by Table 2. Descriptive and comparative table between groups at baseline. Sessions weekly Lifestyle Age (years) Height (cm) Weight (kg) BMI (kg/m2) SF12 – physical (0–100) SF12 – mental (0–100)
2 3 2 3 2 3 2 3 2 3 2 3 2
3 2 3 EuroQol VAS (0–100) 2 3 RMQ (n ¼ 18) (24–0) 2 (n ¼ 18) 3 (n ¼ 18) NDI (n ¼ 18) (0–50) 2 (n ¼ 19) 3 (n ¼ 19) WOMAC (96-0) 2 (n ¼ 19) 3 (n ¼ 19) N 2 3 EuroQol 5D (0–1)
MEAN (SD) 1.65 1.86 50.04 47.38 162.62 163.42 71.25 70.87 26.84 26.37 41.17
(±0.89) (±0.95) (±12.20 (±15.39) (±7.74) (±8.30) (±14.27) (±14.12) (±4.81) (±4.38) (±10.41)
39.75 (±10.83) 47.46 (±10.65) 45.45 (±13.66) 0.72 (±0.21) 0.67 (±0.26) 58.04 (±19.83) 52.64 (±23.45) 7.85 (±4.77) 8.93 (±6.45) 21.87 (±12,86) 23.82 (±14,30) 25.51 (±16.15) 15.30 (±19.28) 58 56
Mean difference
SIG
0.219
0.281
2.66
0.391
0.80
0.656
0.38
0.905
0.47
0.649
1.41
0.549
2.01
0.468
0.05
0.326
5.40
0.269
1.08
0.589
1.95
0.724
10.20
0.270
BMI, body mass Index; SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index.
intention to treat analysis to increase the validity of the results and to improve the internal validity of the study according to the PEDro scale. Data were analysed descriptively and for statistical significance using Statistical Package for the Social Sciences (SPSS) (version 17.0 for Windows, Chicago, IL).
Results Table 2 shows the p values for statistically significant differences, along with the means and standard deviations of the demographic and baseline data between G2 and G3. It can be observed that at the base line no statistically significant differences were found between the experimental groups, in any of the variables analysed indicating that the groups were comparable before the study began. Table 3 shows the results of MPP in G2 and G3. In the G2 it is possible to observe significant differences from baseline in SF-physical and SF-mental dimensions at 8 weeks, 6 months and 12 months of intervention with improvement of 10.42, 16.33 and 15.55 (SF-physical) and 12.56, 25.01 and 27.05 after 8 weeks, 6 month and 1 year of intervention, respectively. In HRQoL (EuroQoL 5D and EuroQoL VAS), the improvement were significant at 8 weeks and 1 year (EuroQoL 5D) and at 8 weeks, 6 months and 1 year (EuroQoL VAS). For specific disability measures, people with LBP improved 2.00 (8 weeks), 2.5 (6 months) and 3.70 (1 year), while improvements were significant 15.68 (8 weeks), 17.09 (6 months) and 17.91 (1 year) for people with CNP and 10.18 (8 weeks) and 18.34 (1 year) for people with OA. Table 3 also shows statistically significant differences in the group G3 during the three time points when the measurements were taken on SF12 Mental (13.88 (8 weeks), 25.01 (6 months), 27.05 (1 year), EuroQoL VAS (+16.33 (8 weeks), +31.75 (6 months), 34.37 (1 year)), RMQ (+2.13 (8 weeks), +3.18 (6 months), +4.10 (1 year)) and WOMAC (5.16 (8 weeks), 6.32 (6 months), 8.95 (1 year). In addition, from baseline, significant improvements were observed in SF 12 Physical, EuroQoL5D and NDI at 8 weeks and 1 year of treatment. Clinically relevant improvement was considered when the percentage differences were higher than 10% [27,26]. Table 4 shows the percentage of the improvement from baseline in all HRQoL and disabilities outcome measures for G2 and G3. Table 5 illustrates the differences between G2 and G3 in the various measurements during the study (baseline, 8 weeks, 6 months and 12 months) of MPP intervention. Only significant differences (p ¼ 0.025) in the variables between the two groups were found in NDI at 8 months from the start of the MPP. Figure 3 illustrates the means for all outcome measures for G2 and G3 at each time point (baseline, 8 weeks, 6 month and 1 year). To summarise the results, both groups improved in their outcomes during the intervention, however, no statistically significant differences were observed between the two groups in the three time points during the study, except for NDI measured at 8 weeks.
Discussion The aim of the study was to determine whether there were any differences in HRQoL and functional ability in PwCMSKD after MPP, when completed either twice or three times a week. The results indicated that there were no significant differences in the short-, medium- and long-term outcomes among patients whether they attended Multi Modal Aquatic Programme either two or three times per week, therefore the null hypothesis, there is not difference in outcomes between two or three weekly sessions, is supported.
Optimal physiotherapy frequency for PwCMSKD
DOI: 10.3109/09638288.2014.918191
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Table 3. Mean improvements from baseline in all health-related quality of life and disabilities outcome measures for G2 and G3. Outcome measure SF12 – Physical (0–100) SF12 – Mental (0–100) EuroQol 5D (0–1) EuroQol VAS (0–100) RMQ (n ¼ 18) (24–0) NDI (n ¼ 18) (0–50)
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WOMAC (n ¼ 17) (96–0)
SW
Baseline (SD)
2 3 2 3 2 3 2 3 2 3 2 3 2 3
41.17 39.75 47.46 45.45 0.72 0.67 58.04 52.64 7.85 8.93 21.87 23.82 25.51 15.30
8 weeks (% improvement)
(±10.41) (±10.83) (±10.65) (±13.66) (±0.21) (±0.26) (±19.83) (±23.45) (±4.77) (±6.45) (±12,86) (±14,30) (±16.15) (±19.28)
51.59* 49.94** 59.92* 59.33* 0.85* 0.82* 74.37** 77.79* 5.85* 6.80* 6.19* 9.53* 15.33* 10.14*
(±12.42) (±10.06) (±9.33) (±8.93) (±0.26) (±0.22) (±18.97) (±20.28) (±1.09) (±1.15) (±4.37) (±8.51) (±11.08) (±12.01)
6 months (% improvement) 57.50** 52.61 72.47* 71.06* 0.89 0.86 81.69** 84.39** 5.38** 5.75 4.78* 6.13 10.37 8.98*
(±12.77) (±11.62) (±10.82) (±11.69) (±0.19) (±0.24) (±18.03) (±19.11) (±1.36) (±1.19) (±3.06) (±4.70) (±9.16) (±7.04)
1 year (% improvement) 57.72* 58.64* 74.51* 75.50* 0.90* 0.88* 84.29* 86.91** 4.15* 4.83* 3.96* 4.91* 7.17* 6.35*
(±11.95) (±12.71) (±8.33) (±14.86) (±0.24) (±0.23) (±19.27) (±20.72) (±1.10) (±1.39) (±3.85) (±2.91) (±18.02) (±3.81)
SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL5D, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index; WOMAC, Western Ontario and McMaster Universities Arthritis Index. Significance value: *p 0.05; **p 0.005.
Table 4. Percentage of improvements from baseline in all health-related quality of life and disabilities outcome measures for G2 and G3. Outcome measure SF12 – Physical (%) SF12 – Mental (%) EuroQol 5D (%) EuroQol VAS (%) RMQ (n ¼ 18) (%) NDI (n ¼ 18) (%) WOMAC (n ¼ 17) (%)
SW 2 3 2 3 2 3 2 3 2 3 2 3 2 3
8 weeks (% improvement) 10.42* 10.19** 12.46* 13.88* 13* 15* 16.33** 25.15* 8.33* 8.88* 31.36* 28.58* 10.60* 5.38*
(±7.22) (±9.81) (±9.64) (±9.06) (±6.6) (±10.26) (±11.69) (±14.51) (±5.81) (±6.25) (±24.87) (±18.04) (±7.05) (±2.61)
6 months (% improvement) 16.33** 12.86 25.01* 25.61* 17 19 23.65** 31.75** 10.29** 13.25 34.18* 35.38 15.77 6.58*
(±10.04) (±10.12) (±16.36) (±14.73) (±11.02) (±13.24) (±17.31) (±23.43) (±8.41) (±9.61) (±21.51) (±19.40) (±10.11) (±4.19)
1 year (% improvement) 16.55* 18.89* 27.05* 30.05* 18* 21* 26.25* 34.27** 15.42* 17.08* 35.82* 37.82* 19.10* 9.32*
(±11.63) (±12.71) (±18.62) (±21.62) (±13.32) (±14.89) (±17.72) (±24.02) (±9.16) (±15.79) (±24.62) (±23.51) (±12.51) (±6.73)
SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL5D, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index; WOMAC, Western Ontario and McMaster Universities Arthritis Index. Significance value: *p 0.05; **p 0.005.
The results indicate that both groups improved significantly at some time point during the year in all of the measured variables. However, after 12 months of intervention, no significant differences were found between the two groups, except for NDI measured at 8 weeks when G2 had significantly better outcomes compared to G3 (Table 5). No studies were found comparing the effect of MPP in PwCMSKD, when performed either two or three times a week and therefore the results of this study cannot be compared to others and are not supported or disputed by other studies to date. However, similar studies on functional outcomes in the CMSKD are published. Rainville et al. (2002) [20] found no significant difference in either the short- (6 weeks) or long-term (12 months) outcomes among people with CLBP when performing a MPP on land (therapeutic exercise and education for health) two or three times a week. The results of the Rainille et al.’s study are comparable to the results of the current study, as people with CLBP can be classified into group of CMSKD. However, the intragroup analysis shows that the improvement in the current study were greater than those in the study by Rainville et al. [20]. This difference may be due to two main factors: the first is that while both studies offered MPPs, their content was different.
In the study presented by Rainville et al. [20], intensive exercises were performed 120 min, whereas in the present study, exercises were used to improve strength and mobility, and the total duration was 60 min. Furthermore, the treatment period in the current study (12 months) was longer than in the study by Rainville et al. (treatment 6 weeks and follow-up 12 months [20]), which might explain the difference in outcomes at 12 months; in the present study, maintenance or improvement of significant variables (SF-12 Physical and WOMAC) was achieved, while this was not the case in the study of Rainville et al. [20]. The variables common to all participants, quality of life and physical and mental health state, showed (Table 3) improvement in HRQoL (EuroQoL 5D and EuroQoL VAS), physical health state and mental health state (Table 3). These results are comparable to those observed in studies of specific musculoskeletal disorders. Specifically, on CNP, different studies [28–30] have shown the effect of a program based on therapeutic exercise, analysing the improvement of HRQoL and disability, although the results are mixed among them. Salo [30] showed improvement in HRQoL of 39% and 37% after 12 sessions when patients were on a home exercise program and these correspond with the results of the current study. Martel [29] observed a moderate improvement
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Table 5. Table to show mean differences and significance between G2 and G3 along the various measurements made during the study. 95% CI Scale
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a
SF-12 Phys (Baseline) SF-12 Phys (8 Weeks)a SF-12 Phys (6 months)a SF-12 Phys (12 months)a SF-12 Mental (baseline)b SF-12 Mental (8 Weeks)b SF-12 Mental (6 months)b SF-12 Mental (12 months)b EuroQol 5D (Baseline)b EuroQol 5D (8 Weeks)b EuroQol 5D (6 months)b EuroQol 5D (12 months)b EuroQol_VAS (Baseline)a EuroQol_VAS (8 Weeks)a EuroQol_VAS (6 months)a EuroQol_VAS (12 months)a RMQ (Baseline)a RMQ (8 Weeks)a RMQ (6 months)a RMQ (12 months)a NDI (Baseline)a NDI (8 Weeks)a NDI (6 months)a NDI (12 months)a WOMAC (Baseline)a WOMAC (8 Weeks)a WOMAC (6 months)a WOMAC (12 months)a
(0–100)
(0–100)
(0–1)
(0–100)
(24–0)
(0–50)
(0–96)
Mean Sig. differences Lower Upper (bilateral) 1.42 1.65 4.89 1.92 2.01 0.59 1.41 0.99 0.05 0.03 0.03 0.02 5.4 3.42 2.7 2.62 1.08 0.95 0.37 0.68 1.95 3.34 1.35 0.95 10.21 1.19 1.39 0.82
3.23 6.06 2.03 6.51 2.53 5.18 3.03 2.88 4.55 5.71 1.50 2.10 3.03 2.03 0.07 0.13 0.07 0.13 0.16 0.06 0.16 0.06 0. 06 0.22 8.96 9.94 4.01 3.59 3.91 6.01 5.02 4.34 4.22 2.92 3.89 2.96 2.63 2.81 2.18 1.58 12.99 9.09 6.94 0.84 3.05 5.96 3.63 4.09 8.80 29.20 3.31 2.89 2.02 3.17 3.41 2.88
0.549 0.307 0.246 0.146 0.914 0.130 0.275 1.000 0.273 0.059 0.383 0.551 0.918 0.896 0.709 0.986 0.571 0.782 0.850 0.621 0.718 0.025* 0.486 0.778 0.270 0.696 0.342 0.913
SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL5D, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index. a Analysis developed by t-test. b Analysis developed by Mann–Whitney U test. Significance value: *p 0.05.
in disability of 5.9, 7.9 and 10.1 (scale: 50–0), in physical health state of 1.8, 2.2 and 4.2 and in mental health state of 0.3, 1.7 and 2.3(scale: 0–100) when measured at 2, 6 and 10 months of a MPP that integrated therapeutic exercise and manual therapy. Falla [28] showed how disability improved 4.7 points on NDI after 6 weeks of neck flexion exercises. These results are inconsistent with those observed in the present study, where improvements in people with CNP, were clinically relevant [27,26] and statistically significant. Moreover, in the specific disability questionnaire of people with CNP, the difference is particularly large in the first evaluation during MPP treatment (8 weeks) (Table 3). It seems that treatment time, which favours patients’ continuing improvement, is one of the factors explaining the differences between the results of the present study with those of Falla et al. and Martel et al. [28,29], but there seem to be other factors contributing to these different results; the first is that the treatment protocols are different, Falla et al. [28] included neck flexion exercises, Martel et al. [29] combination of exercise and manual therapy and in the current study, a protocol included MPP. Another possible explanation could be the period of treatment: in the present study the intervention lasted 12 months versus 6 weeks in Falla et al.’s and Martel et al.’s studies [28,29]. In relation to OA, the results observed in the present study are in line with improvements published by Fransen [31] in terms of perceived disability by patients, which improved in the present study at 8 weeks and 6 months and are consistent with WOMAC improvement previously published. However, the agreement
between studies by Fransen et al. [31] and the present study is not consistent. In the present study, there were improvements in a range between 10.19–16.33 (PHS) and 12.46–25.61 (MHS), while the study of Fransen et al. improvements were 4.6 and 6.8 in the PHS and 0.7 and 0.1 in the MHS intervention after 12 weeks of aquatic therapy and a 6-month follow-up, respectively [31]. Cuesta-Vargas et al. in an earlier studies [16,32] observed an improvement in pain, disability and HRQoL in people with CLBP after MPP for 15 weeks [16] and 4 months [32]. In the latter study, there was a 1-year follow-up; the outcomes were similar to the current study. These data are shown to be consistent with those obtained in a group of PwCMSKD, in general, and people with CLBP, in particular, of this study (Table 3). Specifically, in one study disability improved by 12%, PHS by 10.6% and MHS by 6.4% [16] after 15 weeks, while in the other study [32], improvements were seen, at 8 weeks and 4 months of intervention and also at 1-year follow-up, in disability of 18%, 21% and 24%, respectively, in the PHS of 14.1%, 19.7% and 24.7% and in the MHS of 22.1%, 23.0% and 26.3% [32]. The trend of improvement in the outcome variables experienced by PwCMSKD is apparent as the treatment progresses (Table 3). In the first measurement after the start of the study (8 weeks) a very marked improvement in the outcome variables were shown, but although the improvement continued during the entire intervention period of 1 year it is seen to level out. These results are consistent with those published by Cuesta-Vargas [32], where a great improvement was observed in patients in all variables measured at 8 weeks of intervention, while improvements were attenuated when measured at 6 months and a year. One explanation for this levelling could be that scale of improvement decreases as PwCMSKD progresses in their quality of life, physical and mental health and disability state. So while experiencing a significant improvement in the first 8 weeks, based on the results observed in the present study, treatment for medium or long term (6 months to 1 year) by MPP is recommendable to consolidate and stabilise the improvement experienced by the PwCMSKD. Moreover, in both interventions, present study and in Cuesta-Vargas et al. [32], health education was introduced in the protocol, helping to strengthen the active role that the patient has in the rehabilitation process, favouring the maintenance of the improvements obtained during previous phases of treatment. One of the main strengths of this study is that the intervention lasted for 12 months. This allowed the observation of the effectiveness of treatment and the progression of PwCMSKD in short, medium and long term using self-administered questionnaires. These results should encourage us to reflect about how long should the interventions last for PwCMSKD in order to effect change in behaviour and maintenance of active lifestyle. Further research could explore, the optimum length of intervention period to reach the maintenance with different frequencies of participation. Self-reporting questionnaires are known to have their weaknesses and in this study the dropout in the follow-up response rate may be one of them, yet this was cost-effective way to gather information throughout the study. Completion of the questionnaires in the presence of an interviewer or via a telephone interview may result in better adherence to the follow-up interviews [33]. Conversely, the combination of general HRQoL measures, such as the SF12 and the EuroQol, combined with the disease-specific measures, such as the NDI and RMQ, provide a well-rounded, comprehensive view in general, as well as very specific questions regarding the individuals’ specific circumstances [33]. Although the population sample was limited to persons from only one region of Spain, the sample was fairly large and representative, and therefore the results may be suitable to be carried over to other regions and areas in Europe.
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DOI: 10.3109/09638288.2014.918191
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Figure 3. Graph to show means or an outcome measures for G2 and G3 at each time interval.
This study was set up to investigate whether there were statistically significant differences in the outcomes after an MPP when implemented two or three times a week. The results indicate that the frequency of the treatment sessions did not seem to have influence in those outcomes. It cannot however demonstrate whether the outcomes of the two groups were equivalent and therefore a different kind of research design, i.e. equivalence trial could help to answer this question [34].
Conclusion Results of this study indicate that a statistically significant difference was found between G2 and G3 at 8 weeks for the NDI only. This, however, is a short-term effect that does not carry over into the longer-term either at 6 months or 1 year, thus suggesting that there are no long-term HRQoL differences whether participating in MPP 2 or 3 times a week in this population. There were significant improvements in HRQoL shown in both groups compared to the baseline measures, suggesting that the intervention itself is an effective management approach for these conditions. In people with chronic neck pain no long-term differences in HRQoL were found between 2 and 3 weekly sessions of MPP in persons with CMSKD. Based on the results of this study, it could be recommended that MPP involving aquatic physiotherapy could be recommended to be offered twice a week instead of three times a week to achieve improvement in HRQoL for people with chronic musculoskeletal problems.
Acknowledgements The authors would like to thank all who took part in the intervention and enabled the study to take place.
Declaration of interest No conflicts of interest have been reported by the authors or by any individual involved in writing this article. This information
has not been presented previously. This study did not receive any additional funding as the programme was offered as a part of normal service for this population.
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12. Durstine JL, Moore GE, Painter PE, Roberts SO. ACSM’s exercise management for persons with chronic diseases and disabilities. Champaign (IL): Human Kinetics; 2009. 13. Airaksinen O, Brox JI, Cedraschi C, et al.; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 2006;15:S192–300. 14. Assis MR, Silva LE, Alves AMB, et al. A randomized controlled trial of deep water running: clinical effectiveness of aquatic exercise to treat fibromyalgia. Arthritis Rheum 2006;55:57–65. 15. Cuesta-Vargas AI, Garcı´a-Romero JC, Dediego-Acosta AM, et al. Clinical effect of deep water running on non-specific low back pain: a randomised trial. SA J Physiotherap 2009;65:1–8. 16. Cuesta-Vargas AI, Garcı´a-Romero JC, Arroyo-Morales M, et al. Exercise, manual therapy, and education with or without highintensity deep-water running for nonspecific chronic low back pain: a pragmatic randomized controlled trial. Am J Phys Med Rehabil 2011;90:526–34. 17. Haskell WL, Lee I, Pate RR, et al. Physical activity and public health: updated recommendation for adults from the American college of sports. Medicine and the American Heart Association. Med Sci Sports Exerc 2007;39:1423–34. 18. National Collaborating Centre for Primary Care (UK). Rheumatoid arthritis. The management of rheumatoid arthritis in adults. London: National Institute for Health and Clinical Excellence (NICE); 2009. 19. Sato D, Kaneda K, Wakabayashi H, Nomura T. Comparison of 2year effects of once and twice weekly water exercise on activities of daily living ability of community dwelling frail elderly. Arch Gerontol Geriatr 2009;49:123–28. 20. Rainville J, Jouve CA, Hartigan C, et al. Comparison of short- and long-term outcomes for aggressive spine rehabilitation delivered two versus three times per week. Spine J 2002;2:402–7. 21. Cuesta-Vargas A. Development of software ASETER 2.0 for biomedical assessment before exercise prescription. Torremolinos: Ayuntamiento de Torremolinos; 2007. 22. Vilagut G, Valderas JM, Ferrer M, et al. Interpretation of SF-36 and SF-12 questionnaires in Spain: physical and mental components. Med Clin 2008;130:726–35. 23. Badı´a X, Roset M, Montserrat S, et al. The Spanish version of EuroQol: a description and its applications. European Quality of Life scale. MedClin (Barc) 1999;112:79–85.
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24. Kovacs FM, Llobera J, Gil del Real MT, et al. Validation of the Spanish versio´n of the Roland Morris Questionnaire. Spine 2002;27: 538–42. 25. Andrade Ortega JA, Delgado Martı´nez AD, Alme´cija Ruiz R. Validation of a Spanish version of the Neck Disability Index. Med Clin (Barc) 2008;130:85–9. 26. Escobar A, Quintana JM, Bilbao A, et al. Validation of the Spanish version of the WOMAC questionnaire for patients with hip or knee osteoarthritis. Western Ontario and McMaster Universities Osteoarthritis Index. Clin Rheumatol 2002; 21:466–71. 27. Keller A, Hayden J, Bombardier C, van Tulder M. Effect sizes of non-surgical treatments of non specific low back pain. Eur Spine J 2007;16:1776–88. 28. Falla D, O’Leary S, Farina D, Jull G. The change in deep cervical flexor activity after training is associated with the degree of pain reduction in patients with chronic neck pain. Clin J Pain 2012;28: 628–34. 29. Martel J, Dugas C, Dubois JD, Descarreaux M. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain. BMC Musculoskelet Disord 2011;12:41. 30. Salo PK, Ha¨kkinen AH, Kautiainen H, Ylinen JJ. Effect of neck strength training on health-related quality of life in females with chronic neck pain: a randomized controlled 1-year follow-up study. Health Qual Life Out 2010; 8:48. 31. Fransen M, Nairn L, Winstanley J, et al. Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes. Arthritis Rheum 2007; 57:407–14. 32. Cuesta-Vargas AI, Adams N, Salazar JA, et al. Deep water running and general practice in primary care for non-specific low back pain versus general practice alone: randomized controlled trial. Clin Rheumatol 2012;31:1073–8. 33. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993;118:622–9. 34. Piaggio G, Elbourne DR, Pocock SJ, et al., for the CONSORT Group. Reporting of non inferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. J Am Med Assoc 2012;308:2594–604.
RESEARCH PAPER
The optimal frequency of aquatic physiotherapy for individuals with chronic musculoskeletal pain: a randomised controlled trial Antonio I. Cuesta-Vargas1,2, Melanie White3, Manuel Gonza´lez-Sa´nchez1, and Raija Kuisma3
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1
Departamento de Psiquiatrı´a y Fisioterapia, Instituto de Biomedicina de Ma´laga (IBIMA), Grupo de Clinimetria (AE-14), Universidad de Malaga, Andalucia Tech, Malaga, Spain, 2School of Clinical Sciences, Queensland University of Technology, Brisbane, Australia, and 3School of Health Professions, University of Brigthon, Brigthon, UK Abstract
Keywords
Purpose: To establish whether there was a difference in health-related quality of life (HRQoL) in people with chronic musculoskeletal disorders (PwCMSKD) after participating in a multimodal physiotherapy program (MPP) either two or three sessions a week. Methods: Total of 114 PwCMSKD participated in this prospective randomised controlled trial. An individualised MPP, consisting of exercises for mobility, motor-control, muscle strengthening, cardiovascular training, and health education, was implemented either twice a week (G2: n ¼ 58) or three times a week) (G3: n ¼ 56) for 1 year. Outcomes: HRQoL physical and mental health state (PHS/MHS), Roland Morris disability Questionnaire (RMQ), Neck-Disability-Index (NDI) and Western Ontario and McMaster Universities’ Arthritis Index (WOMAC) were used to measure outcomes of MPP for people with chronic low back pain, chronic neck pain and osteoarthritis, respectively. Measures were taken at baseline, 8 weeks (8 w), 6 months (6 m), and 1 year (1 y) after starting the programme. Results: No statistically significant differences were found between the two groups (G2 and G3), except in NDI at 8 w (3.34, (CI 95%: 6.94/0.84, p ¼ 0.025 (scale 0–50)). All variables showed improvement reaching the following values (from baseline to 1 y) G2: PHS: 57.72 (baseline: 41.17; (improvement: 16.55%), MHS: 74.51 (baseline: 47.46, 27.05%), HRQoL 0.90 (baseline: 0.72, 18%)), HRQoL-VAS 84.29 (baseline: 58.04, 26.25%), RMQ 4.15 (baseline: 7.85, 15.42%), NDI 3.96 (baseline: 21.87, 35.82%), WOMAC 7.17 (baseline: 25.51, 19.10%). G3: PHS: 58.64 (baseline: 39.75, 18.89%), MHS: 75.50 (baseline: 45.45, (30.05%), HRQoL 0.67 (baseline: 0.88, 21%), HRQoL-VAS 86.91 (baseline: 52.64, 34.27%), RMQ 4.83 (baseline: 8.93, 17.08%), NDI 4.91 (baseline: 23.82, 37.82%), WOMAC 6.35 (baseline: 15.30, 9.32%). Conclusions: No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at 8 weeks, but both groups improved in all variables during the course of 1 year under study.
Chronic musculoskeletal disorders, exercise dose, frequency, health-related quality of life, physiotherapy History Received 2 August 2013 Revised 23 February 2014 Accepted 22 April 2014 Published online 12 May 2014
ä Implications for Rehabilitation
A multimodal physiotherapy program (MPP) improves quality of life, overall health, and function in people with chronic musculoskeletal disease after an intervention of short, medium and long term. This implies that twice a week MPP for people with chronic musculoskeletal pain has comparable results to three times a week provision and therefore may have implications in saving resources and cost for patients and service providers without compromising the outcomes of treatment. These results can be considered not only for therapists, but also for managers who offer the services to optimise the balance cost-effectiveness of the proposed interventions.
Background There is contrasting evidence to suggest that chronic pain has a negative impact on physical and psychological health and wellbeing as well as a detrimental impact on activities of daily living,
Address for correspondence: Antonio I. Cuesta-Vargas, PhD, Facultad de Ciencias de la Salud, Universidad de Malaga, Andalucia Tech, Av/ Arquitecto Pen˜alosa s/n (Teatinos Campus Expansion), 29009 Malaga, Spain. Tel: 0034951 952 852. E-mail: [email protected]
employment and economics [1–3]. Chronic pain is a primary symptom of many musculoskeletal disorders, and can be exacerbated or eased by the management of these disorders [2]. Many people with chronic musculoskeletal disorders (CMSKD) have reported being unable to independently care for themselves due to their chronic pain, which impacts heavily on health-related quality of life (HRQoL) [3,4] and on their employment [5]. It is essential that the most effective methods in reducing pain in debilitating chronic diseases are used in their medical and physiotherapy management [6]. There are a multitude of
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guidelines on how to best manage chronic musculoskeletal conditions [7–10], all stating exercise as a common treatment modality. Exercise is considered as part of effective physiotherapy when it reaches a number of criteria, e.g. efficacy, effectiveness, appropriate dose, mechanisms of action and avoidance of potential adverse effects [11]. Recently ACSM guidelines have become more pertinent to populations with chronic diseases and disabilities where exercise is considered to be more relevant to quality of life as opposed to the extension of life [12]. These guidelines could be incorporated in a multimodal exercise programmes with psychological, educational and social aspects. There is strong evidence to support the implementation of these programmes for persons with chronic musculoskeletal diseases [13]. Aquatic exercise has been found to be beneficial for these populations [14–16]. For the CMSKD relevant to this study; chronic low back pain (CLBP), chronic neck pain (CNP) and osteo-arthritis (OA), the ACSM guidelines recommend two to three treatment sessions per week, stating however that ‘‘Many diseases and disabilities have yet to be sufficiently studied to yield exact dose-response information’’ [17]. Additionally, the National Institute for Health and Clinical Excellence (NICE) [8,18] provides incomplete guidelines for exercise dose and prescription and therefore warrant further research into this area. Furthermore, different systematic reviews and clinical practice guidelines have recommended the use of health education as part of physiotherapy programmes for CMSKD [7,8,10,13,14,18]. Some studies have looked into the frequency of exercise sessions comparing one and two sessions a week of aquatic physiotherapy [19], and two and three sessions a week [20] of land-based exercise. However, there is no specific research studies identified to date which investigates dose and frequency for up to three sessions a week of aquatic physiotherapy. In view of the limited evidence of the impact of frequency of exercise therapy on an individual’s quality of life, the aim of the current study was to establish whether there was a difference in HRQoL in people with CMSKD (PwCMSKD) when participating in a multimodal physiotherapy program (MPP) either two or three sessions a week, and whether any differences found between these groups are significant enough to recommend session frequency to be two or three times a week. The results of this study may have implications to the provision of the Aquatic therapy, the cost for the patients and providers and also compliance with the prescribed aquatic therapy programmes. Hypothesis0: there will be no significant differences in HRQoL and disability in PwCMSKD when attending 2 or 3 sessions of MPP.
Methods Study design The study design was experimental prospective study with pre-post intervention evaluation of the outcomes of a MPP, comparing two groups; G2 (2 times a week therapy) and G3 (3 times a week therapy). Data were collected between January 2010 and May 2012 in a community health centre in Torremolinos Spain. The patients were randomly assigned (using sealed envelopes) into one of the two groups either completing two sessions of MPP per week (G2) or three sessions of MPP per week (G3). Participants Inclusion criteria: CMSKD included in this study: chronic non-specific low back pain (CNLBP), chronic neck pain (CNP) or osteoarthritis (OA)) diagnosed by a general practitioner
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at least 12 weeks prior to commencement of the aquatic therapy or persistence pain over 12 weeks. The exclusion criteria were: contraindications to aquatic therapy therefore excluded from the MPP in water, osteoporosis, irregular attendance, infectious process, cognitive impairment of any aetiology, fractures, changes in pharmacological treatment during the intervention time, cancer with or without metastases. Specifically for the CLBP and CNP, patients were excluded if they suffered pain in the spine as a result of specific spinal pathology, nerve root pain/radiculopathy or had a current exacerbation of pain and spinal surgery within 6 months prior to recruitment. In addition, patients with OA were excluded if physical findings indicated the presence of inflammatory arthritis, infections or another autoimmune disease, surgery or trauma on knees and/or hips, within 6 months prior to recruitment. All participants were provided with information of the procedures of the study and they had to sign a written, informed consent before start of the study. Ethics approval from the Consejerı´a de Salud (Distrito Sanitario Costa Del Sol, Servicio Andaluz de Salud) (Spain) and The School of Health Professions Ethical Committee, University of Brighton (England) was obtained before the commencement of the study. The group assignment was randomised. Sealed envelopes were used to allocate each participant either to G2 or G3. The allocator was blinded and he did not know which number corresponded to each intervention group. Total of 131 volunteers were recruited, 17 of them were excluded for failing to meet the criteria for the study. The eligible 114 participants (36 CLBP – 38 CNP – 38 OA) began the MPP, 58 in G2 and 56 in G3. Of these, nine participants did not complete the 1 year long intervention, five in Gr2 and 2 in G3 due to attendance being less than 85% of the sessions in G3, one because moving to another city and another for personal reasons. The analysis of the results includes the data of the 114 participants who began the study. Figure 1 shows a complete flow chart of the participants. Intervention An individualised MPP intervention was implemented and each participant was interviewed and assessed individually by a physiotherapist at the start of their programme using the ASETER 2.0 [21] computer program, which includes a number of relevant lifestyle questions, including smoking, alcohol consumption, activity levels and lifestyle questions. In addition, a physical examination was undertaken to determine the level of functional ability including range of motion, quality of movements and motor control, muscular endurance and strength, and cardiovascular capacity. These however are not reported in this current paper. The therapist who performed the assessments was not involved in interventions with patients. Subsequently an individualised programme was designed involving 10 min of mobility exercise, 10 min training of motor control, 20 min resistance and muscle strengthening exercises and 20 min aerobic exercise in the form of deep water running (DWR) at 55–85% age-predicted maximal heart-rate (Figure 2). During the study the physiotherapist who led the sessions emphasised the importance of regular attendance and adherence to the MPP and also explained the purpose of the exercises and monitored their correct performance. Each session lasted for an hour and the programmes continued for a year, two or three sessions a week depending on which group the participants belonged to. The exercises were instructed and supervised by a physiotherapist and took place in groups in 29–30 C degrees water in a 180–200 cm deep therapy pool.
Optimal physiotherapy frequency for PwCMSKD
DOI: 10.3109/09638288.2014.918191
PRIMARY HEALTH CARE
SELF - DERIVED
SECONDARY HEALTH CARE
HEALTH SECTION (PMDT) PHYSIOTHERAPY SERVICE
VOLUNTARY (N=131) Randomization
GROUP 2 (N=58)
Losses n=5
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5 no adherence
EXCLUDED (n=17) Osteoporosis:n=4 Exercise Intolerance: n=3 Cognitive Impairment: n=1 Non Chronic MSKD=9
313
No Voluntary n=7
GROUP 3 (N=56)
Losses n=4 2 no adherence 1 personal reasons 1 change of city
HEALTH SECTION (PMDT) PHYSIOTHERAPY SERVICE FINAL TREATMENT (12 MOTHS) (N=105) PATIENTS ANALIZED (N=114) Figure 1. Description patient diagram.
Table 1. Table to show outcome measures used for each pathology. Musculoskeletal disorder CLBP
OA
CNP
Figure 2. Participant during deep water running execution.
Outcome measure used 1. Roland Morris Questionnaire (RMQ) 2. SF12: physical state of quality of life related-health (PHS) SF12: Mental state of quality of life related-health (MHS) 3. EuroQol score and VAS 1. Western Ontario and McMaster Universities Arthritis Index (WOMAC) 2. SF12: PHS SF12: MHS 3. EuroQol score and VAS. 1. Neck-Disability-Index (NDI) 2. SF12:PHS SF12: MHS 3. EuroQol score and VAS
HRQoL was assessed by a group of qualified, experienced physiotherapists at the start of the programme (0 weeks), and then 8 weeks, 6 months and 1 year during the programme to determine whether short-term benefits as well as long-term benefits were gained as assessed with fore-mentioned outcome measures (Table 1). The therapists who conducted the assessment and MPP interventions use the outcome measures in their daily practice. They were unaware of which patients were part of this randomised controlled trial. The outcome measures used are deemed to be effective in measuring various aspects of HRQoL for this patient population, as well as being tested for validity and reliability [11,22–26]. The general health-related outcome measures used for all participants as well as specific measures for specific chronic disorders are outlined in Table 1.
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Outcome measures Each patient filled out three self-administered questionnaires, to measure the overall health and quality of life and one to measure disability caused by the specific musculoskeletal disorder. The outcome measures were general health state (physical and mental component), evaluated with the Short Form-12 Health Survey (SF-12) [22]; HRQoL, with the Spanish version of EuroQoL-5D (EuroQoL-5D and EuroQol-VAS [23] and specific disability indices for each musculoskeletal disorder: Roland Morris Questionnaire (RMQ) [24], for CLBP, Neck-DisabilityIndex (NDI) [25], for CNP, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) [26] for OA. The reliability of SF-12 has been shown to be 0.86–0.89 [22], EuroQoL between 0.86 and 0.90 [23], the RMQ Spanish version 0.87 [24], the NDI Spanish version 0.978 [25] and the WOMAC Spanish version between 0.81 and 0.93 [26].
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Data analysis and statistics Kolmogorov–Smirnov test was used to analyse the distribution of the data. To establish whether there were any significant differences between the baseline data for G2 and G3, an independent samples t-test was performed (Table 2). A repeated measures analysis of variance was used to examine statistically significant differences in each group at baseline (0 weeks), 8 weeks, 6 months and 1 year. Within this, sphericity and F values were found to establish the overall significance, as well as pair-wise comparisons to show where any significant values were within the data set. Non-parametric Mann–Whitney U test was employed to find any statistically significant differences between the groups on data that did not fulfil the criteria for parametric testing. Data analysis was performed by Table 2. Descriptive and comparative table between groups at baseline. Sessions weekly Lifestyle Age (years) Height (cm) Weight (kg) BMI (kg/m2) SF12 – physical (0–100) SF12 – mental (0–100)
2 3 2 3 2 3 2 3 2 3 2 3 2
3 2 3 EuroQol VAS (0–100) 2 3 RMQ (n ¼ 18) (24–0) 2 (n ¼ 18) 3 (n ¼ 18) NDI (n ¼ 18) (0–50) 2 (n ¼ 19) 3 (n ¼ 19) WOMAC (96-0) 2 (n ¼ 19) 3 (n ¼ 19) N 2 3 EuroQol 5D (0–1)
MEAN (SD) 1.65 1.86 50.04 47.38 162.62 163.42 71.25 70.87 26.84 26.37 41.17
(±0.89) (±0.95) (±12.20 (±15.39) (±7.74) (±8.30) (±14.27) (±14.12) (±4.81) (±4.38) (±10.41)
39.75 (±10.83) 47.46 (±10.65) 45.45 (±13.66) 0.72 (±0.21) 0.67 (±0.26) 58.04 (±19.83) 52.64 (±23.45) 7.85 (±4.77) 8.93 (±6.45) 21.87 (±12,86) 23.82 (±14,30) 25.51 (±16.15) 15.30 (±19.28) 58 56
Mean difference
SIG
0.219
0.281
2.66
0.391
0.80
0.656
0.38
0.905
0.47
0.649
1.41
0.549
2.01
0.468
0.05
0.326
5.40
0.269
1.08
0.589
1.95
0.724
10.20
0.270
BMI, body mass Index; SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index.
intention to treat analysis to increase the validity of the results and to improve the internal validity of the study according to the PEDro scale. Data were analysed descriptively and for statistical significance using Statistical Package for the Social Sciences (SPSS) (version 17.0 for Windows, Chicago, IL).
Results Table 2 shows the p values for statistically significant differences, along with the means and standard deviations of the demographic and baseline data between G2 and G3. It can be observed that at the base line no statistically significant differences were found between the experimental groups, in any of the variables analysed indicating that the groups were comparable before the study began. Table 3 shows the results of MPP in G2 and G3. In the G2 it is possible to observe significant differences from baseline in SF-physical and SF-mental dimensions at 8 weeks, 6 months and 12 months of intervention with improvement of 10.42, 16.33 and 15.55 (SF-physical) and 12.56, 25.01 and 27.05 after 8 weeks, 6 month and 1 year of intervention, respectively. In HRQoL (EuroQoL 5D and EuroQoL VAS), the improvement were significant at 8 weeks and 1 year (EuroQoL 5D) and at 8 weeks, 6 months and 1 year (EuroQoL VAS). For specific disability measures, people with LBP improved 2.00 (8 weeks), 2.5 (6 months) and 3.70 (1 year), while improvements were significant 15.68 (8 weeks), 17.09 (6 months) and 17.91 (1 year) for people with CNP and 10.18 (8 weeks) and 18.34 (1 year) for people with OA. Table 3 also shows statistically significant differences in the group G3 during the three time points when the measurements were taken on SF12 Mental (13.88 (8 weeks), 25.01 (6 months), 27.05 (1 year), EuroQoL VAS (+16.33 (8 weeks), +31.75 (6 months), 34.37 (1 year)), RMQ (+2.13 (8 weeks), +3.18 (6 months), +4.10 (1 year)) and WOMAC (5.16 (8 weeks), 6.32 (6 months), 8.95 (1 year). In addition, from baseline, significant improvements were observed in SF 12 Physical, EuroQoL5D and NDI at 8 weeks and 1 year of treatment. Clinically relevant improvement was considered when the percentage differences were higher than 10% [27,26]. Table 4 shows the percentage of the improvement from baseline in all HRQoL and disabilities outcome measures for G2 and G3. Table 5 illustrates the differences between G2 and G3 in the various measurements during the study (baseline, 8 weeks, 6 months and 12 months) of MPP intervention. Only significant differences (p ¼ 0.025) in the variables between the two groups were found in NDI at 8 months from the start of the MPP. Figure 3 illustrates the means for all outcome measures for G2 and G3 at each time point (baseline, 8 weeks, 6 month and 1 year). To summarise the results, both groups improved in their outcomes during the intervention, however, no statistically significant differences were observed between the two groups in the three time points during the study, except for NDI measured at 8 weeks.
Discussion The aim of the study was to determine whether there were any differences in HRQoL and functional ability in PwCMSKD after MPP, when completed either twice or three times a week. The results indicated that there were no significant differences in the short-, medium- and long-term outcomes among patients whether they attended Multi Modal Aquatic Programme either two or three times per week, therefore the null hypothesis, there is not difference in outcomes between two or three weekly sessions, is supported.
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Table 3. Mean improvements from baseline in all health-related quality of life and disabilities outcome measures for G2 and G3. Outcome measure SF12 – Physical (0–100) SF12 – Mental (0–100) EuroQol 5D (0–1) EuroQol VAS (0–100) RMQ (n ¼ 18) (24–0) NDI (n ¼ 18) (0–50)
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WOMAC (n ¼ 17) (96–0)
SW
Baseline (SD)
2 3 2 3 2 3 2 3 2 3 2 3 2 3
41.17 39.75 47.46 45.45 0.72 0.67 58.04 52.64 7.85 8.93 21.87 23.82 25.51 15.30
8 weeks (% improvement)
(±10.41) (±10.83) (±10.65) (±13.66) (±0.21) (±0.26) (±19.83) (±23.45) (±4.77) (±6.45) (±12,86) (±14,30) (±16.15) (±19.28)
51.59* 49.94** 59.92* 59.33* 0.85* 0.82* 74.37** 77.79* 5.85* 6.80* 6.19* 9.53* 15.33* 10.14*
(±12.42) (±10.06) (±9.33) (±8.93) (±0.26) (±0.22) (±18.97) (±20.28) (±1.09) (±1.15) (±4.37) (±8.51) (±11.08) (±12.01)
6 months (% improvement) 57.50** 52.61 72.47* 71.06* 0.89 0.86 81.69** 84.39** 5.38** 5.75 4.78* 6.13 10.37 8.98*
(±12.77) (±11.62) (±10.82) (±11.69) (±0.19) (±0.24) (±18.03) (±19.11) (±1.36) (±1.19) (±3.06) (±4.70) (±9.16) (±7.04)
1 year (% improvement) 57.72* 58.64* 74.51* 75.50* 0.90* 0.88* 84.29* 86.91** 4.15* 4.83* 3.96* 4.91* 7.17* 6.35*
(±11.95) (±12.71) (±8.33) (±14.86) (±0.24) (±0.23) (±19.27) (±20.72) (±1.10) (±1.39) (±3.85) (±2.91) (±18.02) (±3.81)
SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL5D, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index; WOMAC, Western Ontario and McMaster Universities Arthritis Index. Significance value: *p 0.05; **p 0.005.
Table 4. Percentage of improvements from baseline in all health-related quality of life and disabilities outcome measures for G2 and G3. Outcome measure SF12 – Physical (%) SF12 – Mental (%) EuroQol 5D (%) EuroQol VAS (%) RMQ (n ¼ 18) (%) NDI (n ¼ 18) (%) WOMAC (n ¼ 17) (%)
SW 2 3 2 3 2 3 2 3 2 3 2 3 2 3
8 weeks (% improvement) 10.42* 10.19** 12.46* 13.88* 13* 15* 16.33** 25.15* 8.33* 8.88* 31.36* 28.58* 10.60* 5.38*
(±7.22) (±9.81) (±9.64) (±9.06) (±6.6) (±10.26) (±11.69) (±14.51) (±5.81) (±6.25) (±24.87) (±18.04) (±7.05) (±2.61)
6 months (% improvement) 16.33** 12.86 25.01* 25.61* 17 19 23.65** 31.75** 10.29** 13.25 34.18* 35.38 15.77 6.58*
(±10.04) (±10.12) (±16.36) (±14.73) (±11.02) (±13.24) (±17.31) (±23.43) (±8.41) (±9.61) (±21.51) (±19.40) (±10.11) (±4.19)
1 year (% improvement) 16.55* 18.89* 27.05* 30.05* 18* 21* 26.25* 34.27** 15.42* 17.08* 35.82* 37.82* 19.10* 9.32*
(±11.63) (±12.71) (±18.62) (±21.62) (±13.32) (±14.89) (±17.72) (±24.02) (±9.16) (±15.79) (±24.62) (±23.51) (±12.51) (±6.73)
SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL5D, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index; WOMAC, Western Ontario and McMaster Universities Arthritis Index. Significance value: *p 0.05; **p 0.005.
The results indicate that both groups improved significantly at some time point during the year in all of the measured variables. However, after 12 months of intervention, no significant differences were found between the two groups, except for NDI measured at 8 weeks when G2 had significantly better outcomes compared to G3 (Table 5). No studies were found comparing the effect of MPP in PwCMSKD, when performed either two or three times a week and therefore the results of this study cannot be compared to others and are not supported or disputed by other studies to date. However, similar studies on functional outcomes in the CMSKD are published. Rainville et al. (2002) [20] found no significant difference in either the short- (6 weeks) or long-term (12 months) outcomes among people with CLBP when performing a MPP on land (therapeutic exercise and education for health) two or three times a week. The results of the Rainille et al.’s study are comparable to the results of the current study, as people with CLBP can be classified into group of CMSKD. However, the intragroup analysis shows that the improvement in the current study were greater than those in the study by Rainville et al. [20]. This difference may be due to two main factors: the first is that while both studies offered MPPs, their content was different.
In the study presented by Rainville et al. [20], intensive exercises were performed 120 min, whereas in the present study, exercises were used to improve strength and mobility, and the total duration was 60 min. Furthermore, the treatment period in the current study (12 months) was longer than in the study by Rainville et al. (treatment 6 weeks and follow-up 12 months [20]), which might explain the difference in outcomes at 12 months; in the present study, maintenance or improvement of significant variables (SF-12 Physical and WOMAC) was achieved, while this was not the case in the study of Rainville et al. [20]. The variables common to all participants, quality of life and physical and mental health state, showed (Table 3) improvement in HRQoL (EuroQoL 5D and EuroQoL VAS), physical health state and mental health state (Table 3). These results are comparable to those observed in studies of specific musculoskeletal disorders. Specifically, on CNP, different studies [28–30] have shown the effect of a program based on therapeutic exercise, analysing the improvement of HRQoL and disability, although the results are mixed among them. Salo [30] showed improvement in HRQoL of 39% and 37% after 12 sessions when patients were on a home exercise program and these correspond with the results of the current study. Martel [29] observed a moderate improvement
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Table 5. Table to show mean differences and significance between G2 and G3 along the various measurements made during the study. 95% CI Scale
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a
SF-12 Phys (Baseline) SF-12 Phys (8 Weeks)a SF-12 Phys (6 months)a SF-12 Phys (12 months)a SF-12 Mental (baseline)b SF-12 Mental (8 Weeks)b SF-12 Mental (6 months)b SF-12 Mental (12 months)b EuroQol 5D (Baseline)b EuroQol 5D (8 Weeks)b EuroQol 5D (6 months)b EuroQol 5D (12 months)b EuroQol_VAS (Baseline)a EuroQol_VAS (8 Weeks)a EuroQol_VAS (6 months)a EuroQol_VAS (12 months)a RMQ (Baseline)a RMQ (8 Weeks)a RMQ (6 months)a RMQ (12 months)a NDI (Baseline)a NDI (8 Weeks)a NDI (6 months)a NDI (12 months)a WOMAC (Baseline)a WOMAC (8 Weeks)a WOMAC (6 months)a WOMAC (12 months)a
(0–100)
(0–100)
(0–1)
(0–100)
(24–0)
(0–50)
(0–96)
Mean Sig. differences Lower Upper (bilateral) 1.42 1.65 4.89 1.92 2.01 0.59 1.41 0.99 0.05 0.03 0.03 0.02 5.4 3.42 2.7 2.62 1.08 0.95 0.37 0.68 1.95 3.34 1.35 0.95 10.21 1.19 1.39 0.82
3.23 6.06 2.03 6.51 2.53 5.18 3.03 2.88 4.55 5.71 1.50 2.10 3.03 2.03 0.07 0.13 0.07 0.13 0.16 0.06 0.16 0.06 0. 06 0.22 8.96 9.94 4.01 3.59 3.91 6.01 5.02 4.34 4.22 2.92 3.89 2.96 2.63 2.81 2.18 1.58 12.99 9.09 6.94 0.84 3.05 5.96 3.63 4.09 8.80 29.20 3.31 2.89 2.02 3.17 3.41 2.88
0.549 0.307 0.246 0.146 0.914 0.130 0.275 1.000 0.273 0.059 0.383 0.551 0.918 0.896 0.709 0.986 0.571 0.782 0.850 0.621 0.718 0.025* 0.486 0.778 0.270 0.696 0.342 0.913
SF-12 Phys, Physical Health State; SF-12 Mental, Mental Health State; EuroQoL5D, Mean Index from EuroQol 5D; EuroQoL VAS, Visual Analogue Scale From EuroQoL 5D; RMQ, Roland Morris Questionnaire; NDI, Neck-Disability-Index. a Analysis developed by t-test. b Analysis developed by Mann–Whitney U test. Significance value: *p 0.05.
in disability of 5.9, 7.9 and 10.1 (scale: 50–0), in physical health state of 1.8, 2.2 and 4.2 and in mental health state of 0.3, 1.7 and 2.3(scale: 0–100) when measured at 2, 6 and 10 months of a MPP that integrated therapeutic exercise and manual therapy. Falla [28] showed how disability improved 4.7 points on NDI after 6 weeks of neck flexion exercises. These results are inconsistent with those observed in the present study, where improvements in people with CNP, were clinically relevant [27,26] and statistically significant. Moreover, in the specific disability questionnaire of people with CNP, the difference is particularly large in the first evaluation during MPP treatment (8 weeks) (Table 3). It seems that treatment time, which favours patients’ continuing improvement, is one of the factors explaining the differences between the results of the present study with those of Falla et al. and Martel et al. [28,29], but there seem to be other factors contributing to these different results; the first is that the treatment protocols are different, Falla et al. [28] included neck flexion exercises, Martel et al. [29] combination of exercise and manual therapy and in the current study, a protocol included MPP. Another possible explanation could be the period of treatment: in the present study the intervention lasted 12 months versus 6 weeks in Falla et al.’s and Martel et al.’s studies [28,29]. In relation to OA, the results observed in the present study are in line with improvements published by Fransen [31] in terms of perceived disability by patients, which improved in the present study at 8 weeks and 6 months and are consistent with WOMAC improvement previously published. However, the agreement
between studies by Fransen et al. [31] and the present study is not consistent. In the present study, there were improvements in a range between 10.19–16.33 (PHS) and 12.46–25.61 (MHS), while the study of Fransen et al. improvements were 4.6 and 6.8 in the PHS and 0.7 and 0.1 in the MHS intervention after 12 weeks of aquatic therapy and a 6-month follow-up, respectively [31]. Cuesta-Vargas et al. in an earlier studies [16,32] observed an improvement in pain, disability and HRQoL in people with CLBP after MPP for 15 weeks [16] and 4 months [32]. In the latter study, there was a 1-year follow-up; the outcomes were similar to the current study. These data are shown to be consistent with those obtained in a group of PwCMSKD, in general, and people with CLBP, in particular, of this study (Table 3). Specifically, in one study disability improved by 12%, PHS by 10.6% and MHS by 6.4% [16] after 15 weeks, while in the other study [32], improvements were seen, at 8 weeks and 4 months of intervention and also at 1-year follow-up, in disability of 18%, 21% and 24%, respectively, in the PHS of 14.1%, 19.7% and 24.7% and in the MHS of 22.1%, 23.0% and 26.3% [32]. The trend of improvement in the outcome variables experienced by PwCMSKD is apparent as the treatment progresses (Table 3). In the first measurement after the start of the study (8 weeks) a very marked improvement in the outcome variables were shown, but although the improvement continued during the entire intervention period of 1 year it is seen to level out. These results are consistent with those published by Cuesta-Vargas [32], where a great improvement was observed in patients in all variables measured at 8 weeks of intervention, while improvements were attenuated when measured at 6 months and a year. One explanation for this levelling could be that scale of improvement decreases as PwCMSKD progresses in their quality of life, physical and mental health and disability state. So while experiencing a significant improvement in the first 8 weeks, based on the results observed in the present study, treatment for medium or long term (6 months to 1 year) by MPP is recommendable to consolidate and stabilise the improvement experienced by the PwCMSKD. Moreover, in both interventions, present study and in Cuesta-Vargas et al. [32], health education was introduced in the protocol, helping to strengthen the active role that the patient has in the rehabilitation process, favouring the maintenance of the improvements obtained during previous phases of treatment. One of the main strengths of this study is that the intervention lasted for 12 months. This allowed the observation of the effectiveness of treatment and the progression of PwCMSKD in short, medium and long term using self-administered questionnaires. These results should encourage us to reflect about how long should the interventions last for PwCMSKD in order to effect change in behaviour and maintenance of active lifestyle. Further research could explore, the optimum length of intervention period to reach the maintenance with different frequencies of participation. Self-reporting questionnaires are known to have their weaknesses and in this study the dropout in the follow-up response rate may be one of them, yet this was cost-effective way to gather information throughout the study. Completion of the questionnaires in the presence of an interviewer or via a telephone interview may result in better adherence to the follow-up interviews [33]. Conversely, the combination of general HRQoL measures, such as the SF12 and the EuroQol, combined with the disease-specific measures, such as the NDI and RMQ, provide a well-rounded, comprehensive view in general, as well as very specific questions regarding the individuals’ specific circumstances [33]. Although the population sample was limited to persons from only one region of Spain, the sample was fairly large and representative, and therefore the results may be suitable to be carried over to other regions and areas in Europe.
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Figure 3. Graph to show means or an outcome measures for G2 and G3 at each time interval.
This study was set up to investigate whether there were statistically significant differences in the outcomes after an MPP when implemented two or three times a week. The results indicate that the frequency of the treatment sessions did not seem to have influence in those outcomes. It cannot however demonstrate whether the outcomes of the two groups were equivalent and therefore a different kind of research design, i.e. equivalence trial could help to answer this question [34].
Conclusion Results of this study indicate that a statistically significant difference was found between G2 and G3 at 8 weeks for the NDI only. This, however, is a short-term effect that does not carry over into the longer-term either at 6 months or 1 year, thus suggesting that there are no long-term HRQoL differences whether participating in MPP 2 or 3 times a week in this population. There were significant improvements in HRQoL shown in both groups compared to the baseline measures, suggesting that the intervention itself is an effective management approach for these conditions. In people with chronic neck pain no long-term differences in HRQoL were found between 2 and 3 weekly sessions of MPP in persons with CMSKD. Based on the results of this study, it could be recommended that MPP involving aquatic physiotherapy could be recommended to be offered twice a week instead of three times a week to achieve improvement in HRQoL for people with chronic musculoskeletal problems.
Acknowledgements The authors would like to thank all who took part in the intervention and enabled the study to take place.
Declaration of interest No conflicts of interest have been reported by the authors or by any individual involved in writing this article. This information
has not been presented previously. This study did not receive any additional funding as the programme was offered as a part of normal service for this population.
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